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What happened at the FDA workshop on testosterone for women

Testosterone treatment for women has been talked about more and more in recent years. Yet in many parts of the world, including the US, there is still no testosterone product specifically approved for women. Could that be about to change?

On 17 September, the US Food and Drug Administration (FDA) held a public workshop on testosterone use in menopausal women, bringing together clinicians, a patient and FDA reviewers to discuss what we know – and where important gaps remain.

Across the day, speakers explored the role testosterone plays in women’s bodies, why measuring testosterone levels isn’t always straightforward, and what current guidelines say about its use. They also discussed dosing, access to treatment and the evidence the FDA would need to consider approving a testosterone product specifically for women.

Importantly, the discussion wasn’t just about the science. One woman shared her experience of spending years without the right diagnosis or treatment, highlighting the real-life impact of gaps in knowledge and care.

Urologist and Sexual Medicine Specialist Dr Rachel Rubin, of Georgetown University, also cited the work of Newson Clinic, which she described as having treated more than 40,000 women with testosterone.

Our summary, which you can download below, takes you through the workshop session by session, with each timecode linking directly to that point in the FDA recording.

It also looks at some of the big questions that remain – including long-term safety, finding the right dose, and whether future research should look beyond low sexual desire.

The FDA is accepting public comments on the workshop until 19 October 2026. Have your say here.

 And you can read more about Newson Research's research on testosterone here.

21 Sep 26
(last reviewed)
Author:
Dr Louise Newson
BSc(Hons) MBChB(Hons) MRCP(UK) FRCGP
Founder, GP and Menopause Specialist
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